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Trial Title:
A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC)
NCT ID:
NCT06530251
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AK112
Description:
Following a predefined dose and date.
Arm group label:
AK112
Arm group label:
AK112 in combination with AK127
Arm group label:
AK112 in combination with AK130
Arm group label:
AK112 in combination with Cadonilimab
Intervention type:
Drug
Intervention name:
Cadonilimab
Description:
Following a predefined dose and date.
Arm group label:
AK112 in combination with Cadonilimab
Intervention type:
Drug
Intervention name:
AK127
Description:
Following a predefined dose and date.
Arm group label:
AK112 in combination with AK127
Intervention type:
Drug
Intervention name:
AK130
Description:
Following a predefined dose and date.
Arm group label:
AK112 in combination with AK130
Intervention type:
Drug
Intervention name:
Sintilimab Injection
Description:
Following the local label direction.
Arm group label:
Sintilimab in combination with Bevacizumab biosimilar
Intervention type:
Drug
Intervention name:
Bevacizumab biosimilar
Description:
Following the local label direction.
Arm group label:
Sintilimab in combination with Bevacizumab biosimilar
Summary:
There're 2 parts in this interventional study:
1. The goal of phase Ib trial is to evaluate the safety and tolerability of AK112 in
combination therapies for the purpose of observing the incidence of dose limit
toxicity (DLT) as well as the confirmation of maximum tolerable dose (MTD) in the
treatment of advanced hepatocellular carcinoma (HCC), so as to determine the
recommended phase 2 dose (RP2D) in the second part of the trial.
2. The goal of phase II trial is to evaluate the safety and efficacy of AK112 in
combination therapy or monotherapy in the treatment of HCC compared to the
combination of Sintilimab and Bevacizumab biosimilar.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Be able and willing to provide written informed consent.
2. Have a life expectancy of at least 3 months.
3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. HCC confirmed by histology/cytology or confirmed by the American Society for the
Study of Hepatology (AASLD) clinical diagnostic criteria for hepatocellular
carcinoma in patients with cirrhosis.
5. Phase Ib:
1. Barcelona Clinical Liver Cancer (BCLC) stage B or C.
2. Has failed standard treatment and has received no more than two lines of
anti-tumor treatment in the past;
Phase II:
1. The BCLC staging is stage C, which is not suitable for curative and local
treatment, or for stage B that cannot be cured after curative and/or local
treatment.
2. Subjects who have not received any systematic anti-tumor treatment for HCC in
the past.
6. According to RECIST v1.1, there is at least one untreatable measurable lesion, or a
measurable lesion with clear imaging progression after local treatment, suitable for
repeated and accurate measurement.
7. Liver function grading Child Pugh Grade A.
8. Has adequate organ function.
9. All subjects of reproductive potential must agree to use an effective method of
contraception, as determined by the Investigator, during and for 120 days after the
last dose of study treatment.
10. Able to to comply with all requirements of study participation (including all study
procedures).
Exclusion Criteria:
1. Components confirmed by histology/cytology, such as fibrous layer hepatocellular
carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma.
2. Except for HCC, the subjects had other malignant tumors within the 5 years prior to
enrollment. Subjects with other malignant tumors that have been cured through local
treatment are not excluded, such as basal or cutaneous squamous cell carcinoma,
superficial bladder cancer, cervical or breast cancer in situ. If diagnosed with
liver cancer or other malignant tumors more than 5 years before administration,
pathological or cytological diagnosis of recurrent and metastatic lesions is
required.
3. Tumor volume>50% liver volume; Portal vein cancer thrombus (Vp4), inferior vena cava
cancer thrombus.
4. Tumors invade important organs and blood vessels around them, and researchers have
determined that entering the study will cause a higher risk of bleeding.
5. There is central nervous system (CNS) metastasis, spinal cord compression, or
meningeal metastasis.
6. There are pleural effusion, pericardial effusion, or ascites with clinical symptoms
or requiring repeated drainage.
7. Previously received immunotherapy, including immune checkpoint inhibitors, immune
checkpoint agonists, immune cell therapy, and any other treatments targeting the
immune mechanisms of tumors.
8. Received local treatment for the liver within 4 weeks prior to the first
administration; Received palliative radiotherapy for non liver patients within 2
weeks prior to initial administration.
9. There is a history of non infectious pneumonia that requires systemic glucocorticoid
treatment, or current lung diseases including but not limited to interstitial lung
disease, pneumoconiosis, silicosis, drug-related pneumonia, and severely impaired
lung function.
10. History of severe bleeding tendency or coagulation dysfunction.
11. Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia.
12. Any arterial or venous thromboembolism events, transient ischemic attacks,
cerebrovascular accidents, hypertensive crises, or hypertensive encephalopathy
occurred within 6 months prior to the first administration of medication.
13. Pregnant or lactating female subject.
14. Any prior or concurrent disease, treatment, or laboratory test abnormality that may
confuse study results, affect subjects' full participation in the study, or may not
be in their best interest to participate.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Contact:
Last name:
Jianqiang Cai
Facility:
Name:
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
Address:
City:
Jinan
Country:
China
Contact:
Last name:
Jinming Yu
Start date:
September 2024
Completion date:
September 2028
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06530251
